Durbin Urges Trade Groups To Take Action Against Tianeptine, An “Opioid-Like” Ingredient Found In Some Products Marketed As Dietary Supplements

CHICAGO – U.S. Senate Majority Whip Dick Durbin (D-IL) urged the Council for Responsible Nutrition, the Consumer Healthcare Products Association, the American Herbal Products Association, and the United Natural Products Alliance to act against the inclusion of dangerous or illegal ingredients in products marketed as dietary supplements in the United States, such as tianeptine. Tianeptine can be found in certain retail outlets, and can create “opioid-like effects,” which can lead to rapid heartbeat, nausea, vomiting, and coma. Tragically, it even has contributed to the deaths of some individuals.

Durbin wrote, “Last month, the Food and Drug Administration (FDA) issued a warning to consumers not to purchase or use products marketed as dietary supplements that include tianeptine. Tianeptine can be found in retail outlets, and can create ‘opioid-like effects.’ It is not approved for use in the United States, but that has not deterred some unscrupulous companies from including it in their products and marketing them as dietary supplements that can treat substance use disorder. Such claims and marketing are illegal actions under the Federal Food, Drug, and Cosmetic Act. It also is cruel to those Americans who experience substance use disorder and need real support—not a cheap, unsubstantiated ‘fix.’ However, recent reporting indicates that tianeptine is reaching and harming consumers now more than ever before.”

According to America’s Poison Centers, there were 11 calls related to tianeptine between 2000 and 2013. However, between 2019 and 2023, there were 1,100 calls related to tianeptine across the United States, with 400 such calls in 2023 alone.

In the letters, Durbin cites an investigative piece by ABC7 Chicago which found that Chris Haggarty, a 37-year-old man from Lorain County, Ohio, died after taking a supplement that included tianeptine last November. Following Mr. Haggarty’s death, ABC7 reported that his mother, Karen, has one wish: to “help other families to avoid going through what [she is] going through right now.”

Durbin’s Dietary Supplement Listing Act of 2022 would require dietary supplement manufacturers to list their products with FDA. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which provided FDA with authorities to regulate dietary supplements. However, DSHEA did not require dietary supplement companies to register their products with FDA—leaving the agency without the much-needed authority or information to properly understand or oversee the market.

The letter continued, “Now, FDA estimates that there are more than 95,000 of these products on the market. But, the agency does not know the true number—let alone what ingredients are included in those products. The Dietary Supplement Listing Act would have given FDA much-needed insight into the market and improved its abilities to initiate enforcement action against the companies that market dangerous or illegal ingredients, such as tianeptine, in their supplement products.”

The letter concluded, “I will reintroduce the Dietary Supplement Listing Act this year. In the face of mounting public health threats, I urge the [Dietary Supplement Trade Association] to help support legislative efforts such as this that would ensure the FDA can protect consumers effectively. I also request that the [Dietary Supplement Trade Association] provide my office with a written plan to work with responsible supplement manufacturers to remove tianeptine and other dangerous or illegal ingredients from the supplement market. Let me be clear: we must take substantive action to ensure that other mothers, fathers, siblings, and friends do not experience the same pain and suffering that Karen faces now.”

Full text of the letter to the Council for Responsible Nutrition can be found here.

Full text of the letter to the Consumer Healthcare Products Association can be found here.

Full text of the letter to the American Herbal Products Association can be found here.

Full text of the letter to the United Natural Products Alliance can be found here.

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